A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant ...

The same company whose infant formula is now under recall in relation to an outbreak of botulism poisoning cases recalled its ...

The U.S. FDA inspection of the facility, Unit-II in Bhiwadi, Alwar, from November 3-14 concluded with nine observations. They are procedural in nature and will be responded to within the stipulated ...

May 6 (UPI) --The U.S. Food and Drug Administration said Tuesday it will expand its use of unannounced inspections at foreign manufacturing facilities. "For too long, foreign companies have enjoyed a ...

Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of the largest employers in Lexington, has continued to face federal ...

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other ...

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...